Trials / Terminated
TerminatedNCT03391050
A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma
A Phase Ib/II Study to Investigate the Safety and Clinical Activity of APR-246 in Combination With Dabrafenib in Patients With BRAF V600 Mutant Unresectable and/or mEtastatic Cutaneous MElanoma Resistant to Dabrafenib/Trametinib Combination
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Aprea Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and dabrafenib therapy regimen in patients with BRAFV600 mutant unresectable and/or metastatic cutaneous melanoma resistant to the dabrafenib/trametinib combination. In addition, the study aims to assess the safety profile of the combined APR-246 and dabrafenib therapy regimen, to explore potential biomarkers, and to further describe the anti-tumour activity of the combination of APR-246 and dabrafenib. The trial will enroll up to 31 evaluable patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APR-246 | Intravenous infusion |
| DRUG | Dabrafenib | Oral administration |
Timeline
- Start date
- 2018-01-18
- Primary completion
- 2018-08-08
- Completion
- 2018-08-08
- First posted
- 2018-01-05
- Last updated
- 2019-07-31
Locations
3 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03391050. Inclusion in this directory is not an endorsement.